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Drug Licence

  • Mandatory legal approval to deal in drugs and medicines
  • Ensures compliance with drug safety and quality laws
  • Builds trust with customers, hospitals, and suppliers
  • Essential for wholesale, retail, manufacturing, and distribution
  • Prevents penalties, seizure of stock, and business closure
  • Provides mandatory legal authorization to manufacture, distribute, or sell drugs and medicines.
  • Prevents penalties, seizure of stock, and criminal prosecution.
  • Builds trust with regulators, hospitals, pharmacies, and consumers.

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Experience Icon

7 Years

Of Experience

Cases Solved Icon

3622 +

Cases Solved

Awards Gained Icon

10 +

Awards Gained

Trusted Clients Icon

144 k +

Trusted Clients

Queries Solved Icon

36 k+

Queries Solved

Experience Icon

7 Years

Of Experience

Cases Solved Icon

3622 +

Cases Solved

Awards Gained Icon

10 +

Awards Gained

Trusted Clients Icon

144 k +

Trusted Clients

Queries Solved Icon

36 k+

Queries Solved

Experience Icon

7 Years

Of Experience

Cases Solved Icon

3622 +

Cases Solved

Awards Gained Icon

10 +

Awards Gained

Trusted Clients Icon

144 k +

Trusted Clients

Queries Solved Icon

36 k+

Queries Solved

Overview

Introduction

A Drug Licence is a compulsory statutory licence required to manufacture, sell, stock, distribute, or import drugs and medicines in India. It is issued under the Drugs and Cosmetics Act, 1940, to ensure that medicines and pharmaceutical products sold in the market are safe, effective, and of standard quality.
Any business dealing with allopathic, ayurvedic, homeopathic, cosmetic drugs, medical devices, or pharmaceuticals must obtain the appropriate Drug Licence before starting operations. Depending on the nature of activity, the licence may be required for retail sale, wholesale supply, manufacturing, or loan licensing.
Drug Licences are issued by State Drug Control Departments, while certain approvals such as import licences and large manufacturing permissions are regulated by the Central Drugs Standard Control Organization (CDSCO). Operating without a valid Drug Licence is a serious offence and can result in seizure of medicines, cancellation of business, heavy penalties, and imprisonment.

Governing Authority

Drug Licence is governed by the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.
  • State Drug Control Department issues Retail and Wholesale Drug Licences
  • Central Drugs Standard Control Organization (CDSCO) regulates import and certain manufacturing licences

Importance of the Registration

This licence ensures that drugs sold or manufactured meet prescribed quality and safety standards. It helps prevent the circulation of spurious or substandard medicines and is mandatory for pharmacies, medical stores, distributors, and pharmaceutical companies.

Businesses Require This Registration

  • Retail medical stores and pharmacies
  • Wholesale drug distributors and stockists
  • Pharmaceutical manufacturing units
  • Importers of drugs and medical devices
  • Online medicine sellers and e-pharmacies

Objective of Compliance

The objective is to regulate the drug supply chain, ensure public health safety, control the quality of medicines, and hold drug businesses accountable under State and Central drug laws.

Documents Required

Documents
  • 1 Identity proof of proprietor
  • 2 Address proof of proprietor
  • 3 PAN of proprietor
  • 4 Proof of business premises
  • 5 Qualification and registration certificate of pharmacist/competent person • Appointment letter of pharmacist
  • 1 PAN of partnership firm
  • 2 Partnership Deed
  • 3 Identity and address proof of partners
  • 4 Proof of business premises
  • 5 Qualification and registration certificate of pharmacist/competent person
  • 1 Certificate of Incorporation
  • 2 PAN of company/LLP
  • 3 MOA & AOA / LLP Agreement
  • 4 Identity and address proof of directors/partners
  • 5 Proof of registered office/business premises
  • 6 Appointment and qualification details of pharmacist/competent person
  • 7 Board Resolution or Authorization Letter

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Eligibility

Applicability

Applicable to businesses dealing in drugs or medicines
Applicable to retail, wholesale, manufacturing, and import activities
Applicable to both physical and online sale of medicines
Applicable irrespective of business turnover

Eligibility

Applicant must be a legally registered entity
Premises must meet storage and infrastructure norms
Appointment of qualified pharmacist or competent person is mandatory
Compliance with drug safety and storage standards is required

Validity

Drug Licence is generally issued for a period of 5 years
Validity depends on state-specific rules
Renewal must be applied before expiry
Late renewal may attract penalties or cancellation

Non-Complianc

Non-Complianc

Seizure and confiscation of drugs
Heavy monetary penalties
Suspension or cancellation of Drug Licence
Imprisonment in cases of serious violations

FAQs

Is Drug Licence mandatory for medical shops?

Yes, every retail or wholesale medical store must obtain a valid Drug Licence.

Who issues Drug Licence in India?
Is a pharmacist mandatory for Drug Licence?
Is Drug Licence required for online medicine selling?
What happens if drugs are sold without a licence?
What is a Drug Licence?
Is Drug Licence mandatory for all medical shops?
Are there different types of Drug Licences?
Does a Drug Licence require renewal?
What happens if drugs are sold without a licence?

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What Our Clients Say

Discover what our satisfied clients have to say about their experience working with us

Sandeep Reddy
Founder, Retail Trading Business
" ARK Advisors made our audit process smooth and stress-free. Clear checklist, timely follow-ups, and very practical guidance. "
Anusha Sharma
Partner, Professional Services Firm
" Their team quickly identified compliance gaps and suggested actionable fixes. Reporting was crisp and easy for management to understand. "
Rohit Kulkarni
CFO, Manufacturing Unit
" We got strong process recommendations and control improvements. The audit insights genuinely helped us reduce leakage and improve discipline. "
Meghana Rao
Director, Startup
" Professional, responsive, and very transparent. They explained everything in simple terms and kept the entire process on schedule. "
Imran Khan
Owner, Hospitality Business
" The team ensured our documentation was audit-ready and supported us throughout. Great experience and strong attention to detail. "

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